An open-labeled phase II trial of docetaxel in combination with cisplatin as first-line cytotoxic therapy for anthracycline-naive patients with metastatic breast cancer.

The combination of docetaxel and cisplatin has shown promising results in anthracycline-pretreated patients with advanced breast cancer, but with substantial toxicity. The efficacy and safety in anthracycline-naive patients has not been evaluated. Between October 2003 and January 2006, we enrolled 39 patients. None had undergone chemotherapy for metastatic disease or been exposure to adjuvant anthracycline-based regimens earlier. Eligibility criteria included: histologically proven metastatic cancer; WHO performance status (PS) 0-2; and adequate hematological, hepatic and renal function. Docetaxel (70 mg/m) and cisplatin (50 mg/m) were administered every 3 weeks until the patient either refused to continue, or progression, or even unacceptable toxicity occurred. Tumor response was assessed every three cycles. One patient was withdrawn from response analysis because of toxicity. Thirty-eight patients had a complete tumor assessment. Median age was 50 years (range, 28-63); 5.1% had a WHO of PS of 0; 87% a PS of 1; 7.7% a PS of 2; in 69%, two or more organs were involved. A total of 291 cycles (range, 1-9) were administered. Three complete responses and 27 partial responses (intent-to-treat response rate 30/39=76.9%) resulted; disease remained stable in six patients and two had disease progression. Grade III/IV toxicities included diarrhea in 10.2%, asthenia/fatigue in 2.5%, mucositis in 5.1% and neutropenia in 87.3% of patients. Seven patients developed febrile neutropenia (17.9%). The median time to progression was 11.2 months; the timespan was not sufficient to track the median survival. Docetaxel/cisplatin is an active regimen with acceptable toxicity in the first-line treatment of metastatic breast cancer, but it is not sufficiently promising as a standard. Further randomized study is warranted.